Label: PAIN RELIEF LIQUID- menthol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 5, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Menthol 16%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    temporariy relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
  • WARNINGS

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight

    Flammable

    • keep away from fire or flame
  • STOP USE

    stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again witin a few days sy
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help, or contact a Poison control Center right away

  • INSTRUCTIONS FOR USE

    Adults and children over 12 years;

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3-4 times daily
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    children 12 years or younger: ask a doctor

  • INACTIVE INGREDIENT

    acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (3

    0%), water (245-256)

  • DESCRIPTION

    Personal Care Solutions

    Maximum Strength

    Pain Relief Liquid

    with no mess roll-on applicator

    Long lasting pain relief

    • Powerful, fast acting formula
    • Deep Penetrating Quick Drying
    • Roller Ball Keeps Hands Clean

    2.5 fl. oz. (73 ml)

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed int skin
    • repeat as necessary, but no more than 3-4 times daily.
  • PRINCIPAL DISPLAY PANEL

    Liquid Roll on pain relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF LIQUID 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-402-0273 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/05/2016
    Labeler - Great Lakes Wholesale, Marking, and Sales, Inc. (361925498)
    Registrant - Illinois Industrial Tool, Inc (628032898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Dedi Medical Device Co., Ltd.421353662manufacture(64092-402)